Watson reports positive oxybutynin phase III results for OAB

Watson Pharmaceuticals reports positive results from its late stage trial of oxybutynin topical gel in patients with overactive bladder

US-based Watson Pharmaceuticals has reported positive results from its late stage trial of oxybutynin topical gel (OTG) in patients with overactive bladder (OAB).

The company said that the study met its primary endpoint and secondary endpoints. The phase III study is a multi-centre, double blind, placebo-controlled trial designed to evaluate the efficacy and safety of OTG in 789 patients with OAB.

The primary objective of the study was to demonstrate that daily treatment of a one-gram dose of OTG for 12 weeks was superior to placebo for the relief of OAB symptoms.

In addition, 216 patients participated in a 14-week, open label, safety-extension study for a total of 26 weeks. During the double-blind portion of the trial, highly statistically significant improvements relative to placebo were seen on all of these endpoints, according to Watson.

The study data showed that OTG was well tolerated in the study and no serious adverse events related to the treatment were reported.

Watson plans to submit NDA for OTG with the FDA in Q2 2008, adding that the product would be the first gel formulation for the treatment of OAB in 2009.

Shares in Watson were up USD 0.12 to rest at USD 26.20 in trading on 7 January 2008.